Abstract
A new generation of diagnostic tests is being developed for use at the point of care that could save lives and reduce the spread of infectious diseases through early detection and treatment. It is important that patients in developing countries have access to these products at affordable prices and without delay. Regulation of medical products is intended to ensure safety and quality whilst balancing the need for timely access to beneficial new products. Current regulatory oversight of diagnostic tests in developing countries is highly variable and weak regulation allows poor-quality tests to enter the market. However, inefficient or overzealous regulation results in unnecessary delays, increases costs and acts as a barrier to innovation and market entry. Setting international standards and streamlining the regulatory process could reduce these barriers. Four priority activities have been identified where convergence of standards and protocols or joint review of data would be advantageous: (1) adoption of a common registration file for pre-market approval; (2) convergence of quality standards for manufacturing site inspections; (3) use of common evaluation protocols, as well as joint review of data, to reduce unnecessary duplication of lengthy and costly clinical performance studies; and (4) use of networks of laboratories for post-market surveillance in order to monitor ongoing quality of diagnostic devices. The adoption and implementation of such measures in developing countries could accelerate access to new diagnostic tests that are safe and affordable.
Highlights
Diagnostic tests make a major contribution to global health
Most diagnostic interventions utilise in vitro diagnostic medical devices (IVDs) which test specimens obtained from a patient, such as blood or urine
IVDs include a wide range of technologies, from rapid dip-stick strips for use at the point of care (POC) to sophisticated instrumentation for use in referral laboratories
Summary
Diagnostic tests make a major contribution to global health. They are needed in order to guide treatment decisions and ensure the appropriate use of medicines. Most countries have a legal framework and a nominated body to regulate medicines, but regulation of medical devices in developing countries is less common.[8] The demands on regulatory authorities for IVDs differ from that of other medical products in that there are a very large number of IVDs and, compared with drugs or vaccines, their market life is often short given the rapid pace of technology development.[9] Current regulatory oversight of IVDs is variable[8] and, in countries where there is no regulation, substandard and counterfeit tests may be sold openly.[10] In countries that do regulate, approval for IVDs is often costly, lengthy and, on occasion, lacking in transparency, regulation of diagnostics is currently seen as a barrier to innovation and access.[9,11,12] In 2001, the Pan American Health Organisation (PAHO), the Regional Office for the Americas of the World Health Organization (WHO) and the United States Food and Drug Administration (USFDA) published a model regulatory programme for medical devices, with a set of guiding principles.[13] These principles include the statement that: regulatory system should ensure that valuable new technologies are made available to the clinical community and to patients and consumers expeditiously while preventing unsafe or ineffective devices from reaching the market.[13] They state that regulatory decisions must be based on strong and clear science, free of external influences and, in addition, that countries instituting regulatory programmes should be cognisant of ongoing international efforts to harmonise activities.
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